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PainPhase 3NCT01132794

A Study to Assess the Analgesia and Sedation Using Intranasal Dexmedetomidine in Third Molar Surgery Under Local Anaesthesia

A Phase 3 study testing Intranasal dexmedetomidine in people with Pain and Sedation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation. Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Pain, Sedation
What is being tested?
Intranasal dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteHong Kong
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) 1 or 2
  • Age >18 and less than 40 years
  • Unilateral wisdom tooth removal
  • Written informed consent

Who cannot join

  • Allergy to dexmedetomidine and propofol
  • Patient refusal
  • Mentally unfit
  • Impaired renal or hepatic function
  • Pregnant
  • Exposure to study drug within the past 3 months.
Show all 11Show fewer
  • Use ofα2 agonists currently
  • Patients with cardiac disease
  • Abnormal electrocardiogram
  • Inability to complete psychomotor test
  • Addictive in illicit drugs or alcohol

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Department of Anaesthesiology, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Dental procedures such as wisdom tooth removal evoke very high levels of patients' anxiety and it is, therefore, common practice to provide concomitant pharmacologic sedation.

Sedative agents can be administered by the oral, rectal, intra muscular and intravenous routes. The oldest, safest and most convenient route at present is the oral route. However, as Uygur-Bayramicli et al. mentioned that administering the drugs orally can result in problems like delayed effect. Intranasal administration is a straightforward procedure. It is simple and relatively painless. Although it may be objectionable, less patient cooperation is required than with oral administration, especially in which the child must swallow the medication.

Read more

Many studies on dental sedation have been carried out by anesthesiologists but there is no ideal drug that can offer effects of both sedation and analgesia. Some drugs offer only one effect and others are not safe enough for clinical use. Midazolam, a benzodiazepine drug, is the traditional choice for sedation, but it has properties such as relatively slow onset and no analgesia. Propofol is an alkylphenol sedative and hypnotic agent with a rapid onset and offset. It has been used in patient controlled sedation before. But it has no analgesic properties. It can provide some antegrade amnesia, but it is not as reliable an amnestic as the benzodiazepine drugs. Because of these characteristics, propofol often is supplemented with narcotics and benzodiazepines. Although not irritant, it can cause pain during intravenous infusion.

A new drug, an alpha agonist with its relatively high ratio of α2/α1-activity (1620:1 as compared with 220:1 for clonidine) of theα2 receptor is dexmedetomidine. This property may lead to more potent effects of both sedation and analgesia without unwanted cardiovascular effects fromα1 receptor activation. Most of the data evaluating the use of dexmedetomidine in the intensive care unit (ICU) were obtained in the immediate postoperative period, mainly in patients who underwent open-heart surgery. Currently, clinicians are awaiting studies in broader patient populations. In the studies that have been completed to date, sedation has been attained easily with maintenance of respiratory function. Patients are readily arousable. There is a minimal increase in blood pressure initially, followed by a slight decrease in blood pressure. Lower dose ranges, avoidance of rapid bolus injection, and a slow rate of administration tend to decrease these circulatory side effects. So many clinical studies have shown that it can be well and safely used intravenously, intramuscularly and transdermally. Although not an officially technique, there are also reports of intranasal administration resulting in fairly predictable onset in both adults and children.

The investigators propose that intranasal can help to improve postoperative pain relief with better sedation.

Conditions
Pain, Sedation
Being tested
Intranasal dexmedetomidine, Placebo
Keywords
Pain relief and sedation condition
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal dexmedetomidineDrug

    1mcg per kg dexmedetomidine given intranasally 45 minutes before operation

  • PlaceboDrug

    Intranasal nasal saline

Study groups in NCT01132794
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIntranasal nasal saline
Receives: Drug: Placebo
DexmedetomidineActive comparatorIntranasal dexmedetomidine
Receives: Drug: Intranasal dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain scores after operation

Secondary outcomes (1)
  1. Sedation satisfaction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
IDs, dates and publications
ClinicalTrials.gov ID
NCT01132794
Sponsor's protocol ID
200707176037
Status last verified
May 2010
First submitted
24 May 2010
Last updated
16 Jun 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intranasal dexmedetomidine in people with Pain and Sedation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores after operation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.

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